Keywords
eustachian tube - valsalva maneuver - otitis media
Introduction
Prior treatment of Eustachian tube dysfunction (ETD) is crucial for the success of
any middle ear surgery in chronic otitis media (COM). However, many physicians tend
to ignore this as the treatment is cumbersome, expensive, or inaccessible. Balloon
dilation, even though the standard of care, is expensive and not universally available,
mainly in developing countries. There is a need to look for more straightforward and
cheaper alternatives that are readily available. In this background, we evaluated
the use of Eustachian barotubometer (EBT) ([Fig. 1]) to treat obstructive ETD (OETD) in mucosal COM.[1],[2]
Fig. 1 Prototype of the Eustachian barotubometer designed by the first author.
Materials and Methods
This pilot study was undertaken in 1 year in a tertiary referral public hospital after
obtaining the necessary clearance from the institutional review board (KIMS/EC/68/2019-20).
This study was also registered in the clinical trials registry of India (2020/10/037763).
Written informed consent was taken from all the adult patients with mucosal COM (quiescent
and dry stages only) for the study. All eligible patients were confirmed to have complete
ETD using the EBT before assigning to the groups.[1]
Method of Testing Eustachian Tube Function with EBT
For the physiological opening test, the patient was in the sitting position; an earplug
of the EBT was applied to the ear canal. Air pressure in the canal was raised up to
40 mm in the dial and the patient was asked to dry swallow voluntarily multiple times.
If the air pressure fell in the dial of the EBT, it meant that the Eustachian tube
opened physiologically and if the air pressure did not drop, it meant that the Eustachian
tube was partially blocked.
For the forced opening test, a patient in the same sitting position was asked to do
the Valsalva maneuver (VM) with pressure in the dial at zero. If the pressure in the
dial of the EBT rose, it meant that the forced opening of the Eustachian tube was
present. If the pressure dial did not raise, it meant that the forced opening of the
Eustachian tube was absent and hence the Eustachian tube was completely blocked.
They all underwent diagnostic nasal endoscopy (DNE) to rule out persistent adenoids
or any other mass in the nasopharynx or nasal cavity. They also underwent otoendoscopic
evaluation to rule out cholesteatoma, granulation, and pus in the middle ear. Cases
included those who underwent Eustachian barotubometer therapy (EBTT) twice a day,
while controls performed VM with dry swallows 10 times a day. These exercises were
performed every day for 10 days or until the Eustachian tube opened, whichever was
earlier.
The Procedure of the EBTT
The patient was in the sitting position, and the pressure in the middle ear of the
dysfunctional side was raised to 50 mm Hg by sealing the ear canal with the ear tip
and maintaining the same force for one minute. The patient was asked to dry swallow
multiple times after the procedure. EBT test was repeated between the therapy procedures
to verify the opening of the Eustachian tube.
Both the groups were also treated with Ciprofloxacin Dexamethasone ear drops (Ciplox-D,
Ciprofloxacin 0.3% w/v, dexamethasone sodium phosphate 0.1% w/v, and benzalkonium
chloride 0.01% w/v manufactured by Cipla Ltd., Village Sachana, Viramgam Taluk, Ahmedabad
- 382150, Gujarat, India) and Xylometazoline nasal drops (Xylomist, xylometazoline
hydrochloride 0.1% w/v, benzalkonium chloride 0.022% w/v manufactured by Zydus Healthcare
Ltd., 75/1, GIDC, Valsad District, Vapi - 396195, Gujarat, India) thrice a day. Number
of days taken for opening of Eustachian tube among cases and controls was noted. If
the ET opened partially (only forced opening present) or completely (both forced and
physiological opening present), then the outcome was considered a success. If the
Eustachian tube failed to recover even at the end of 10 days, the outcome was considered
a failure.
The data were entered in SPSS software version 17 and analyzed using independent “t”
test and chi-square test with a confidence interval of 95%.
Results
Twenty-five cases and 30 controls with COM and ETD were enrolled for the study. The
demographic characteristics of the patients are given in [Tables 1] and 2[]. All of them underwent DNE and the findings were not significantly different between
the groups ([Table 3]). The number of patients who recovered completely from ETD was more than those who
recovered partially in both groups. The success rate of the cases was 92%, while it
was 46.66% for the controls and this difference was highly significant ([Table 4]). The average number of days taken for partial recovery was 4.2 and 5.3 days for
cases and controls, respectively. For complete recovery, it was 5 and 7.9 days. The
time taken for the recovery of the Eustachian tube was compared between the cases
and controls for partial and complete responses in [►Tables 5] and [6], respectively. Again, the difference between the cases and controls for complete
recovery was highly significant, suggesting that the recovery was much faster with
EBT than with VM. No complications were observed with EBTT.
Table 1
Sex distribution of the cases and controls
|
Patients
|
Cases
|
Controls
|
Total
|
|
Males
|
6
|
8
|
14
|
|
Females
|
19
|
22
|
41
|
|
Total
|
25
|
30
|
55
|
Chi-squared test p-value: 0.83.
Table 2
Analysis of age in cases and controls
|
Groups
|
Number
|
Mean
|
SD
|
Min-max
|
p-Value
|
|
Cases
|
25
|
29.9
|
13.0
|
11–63
|
0.83
|
|
Controls
|
30
|
30.7
|
16.1
|
7–70
|
Abbreviation: SD, standard deviation.
Independent t-test, p-value—not significant.
Table 3
Diagnostic nasal endoscopy findings in the cases and controls
|
DNE findings
|
Cases, n
|
Controls, n
|
Total, n
|
|
Adenoid grade 1
|
7
|
2
|
9
|
|
DNS
|
16
|
16
|
32
|
|
Inferior turbinate hypertrophy
|
4
|
9
|
13
|
|
Nasal allergy
|
0
|
1
|
1
|
Abbreviations: DNE, diagnostic nasal endoscopy; DNS,deviated nasal septum.
Chi-squared test p-value = 0.12.
Table 4
Recovery status of the cases and controls in 10 days
|
Recovery status of ET
|
Cases, n
|
Controls, n
|
Total, n
|
|
Complete recovery
|
15 (60%)
|
10 (33.33%)
|
25
|
|
No recovery
|
2
|
16
|
18
|
|
Partial recovery
|
8 (32%)
|
4 (13.33%)
|
12
|
|
Total
|
25
|
30
|
55
|
Abbreviation: ET, Eustachian tube.
Chi-squared test p-value: 0.001.
Table 5
Duration required for the partial recovery of the Eustachian tube in the study groups
|
Duration in days
|
Cases
|
Controls
|
Total
|
p-Value
|
|
4
|
1
|
0
|
1
|
0.05
|
|
5
|
1
|
0
|
1
|
|
6
|
1
|
0
|
1
|
|
7
|
3
|
2
|
5
|
|
> 7 < 10
|
2
|
1
|
3
|
|
10
|
0
|
1
|
1
|
|
Total
|
8
|
4
|
12
|
Table 6
Duration required for the complete recovery of the Eustachian tube in the study groups
|
Duration in days
|
Cases
|
Controls
|
Total
|
p-Value
|
|
3
|
1
|
0
|
1
|
< 0.001
|
|
4
|
4
|
0
|
4
|
|
5
|
3
|
0
|
3
|
|
6
|
4
|
0
|
4
|
|
7
|
3
|
8
|
11
|
|
> 7 < 10
|
0
|
0
|
0
|
|
10
|
0
|
2
|
2
|
|
Total
|
15
|
10
|
25
|
Discussion
ETD remains a poorly understood disease whose management is unclear.[3] Among the general population in the United States, ETD has a prevalence of 4.6%
among adults and 6.1% among the children.[4] There can be 3 types of ETD and diagnosis has to be based on history and clinical
examination: (1) dilatory or OETD, (2) bar-challenge-induced ETD, and (3) patulous
ETD.[3],[5] Dilatory ETD can be further broken down into (A) functional obstruction, (B) dynamic
obstruction (muscular failure), and (C) anatomical obstruction.[5] There is a wide range of Eustachian tube function tests; however, none can be considered
a “gold standard.”[6] Although many are reported to determine Eustachian tube function with a reasonable
degree of accuracy, the optimal assessment tool for the complex spectrum of ETD disorders
lies in a combination of objective clinical tests and patient-reported measures.[6] Mucosal edema at the Eustachian tube orifice has been noted in 83% of patients with
ETD.[7] There is also a strong correlation between mucosal inflammation and laryngopharyngeal
reflux and allergic rhinitis.[8] Because of this association, it is a common practice to prescribe nasal steroids
as the first-line treatment for ETD.[3]
Even though this disorder is quite common, opinions differ widely among otolaryngologists
on managing these patients.[3] There is no doubt that OETD needs to be treated before any middle ear surgery for
COM.[9],[10] Conservative methods like VM and others have been tried before, both to confirm
the diagnosis of patency of Eustachian tube and force open an obstructed tube.[11] However, these maneuvers have their limitations. They are challenging to be performed
in children who represent a significant chunk of the cases of COM. Besides, the pressure
built up inside the Eustachian tube voluntarily is often unreliable and inadequate,
especially in children. Also, when both eardrums are perforated in a patient, these
maneuvers are even more challenging to perform. Hence, we thought upon the EBT inflation-deflation
therapy to overcome many of these drawbacks.[1],[2] Besides, it is cost-effective, portable, noninvasive, is not driven by power and
hence can be used quickly and conveniently without anesthesia. It can be used even
by a layperson with some training in both adults and children in the peripheral health
care setup. To the best of our knowledge, there is no such study reported in the literature
so far.
Our procedure does not risk facilitating the regurgitation of the nasopharyngeal and
nasal infections into the middle ear unlike the VM. Since our procedures were performed
only in the quiescent and dry stage of mucosal COM, the mucosal edema inside the Eustachian
tube was absent and hence there were very few failures in the case group. The failures
were primarily due to the noncompliance by the patient, who was unduly sensitive to
the pressure build-up inside the middle ear. The air leak at the earplug tip was yet
another problem. Sometimes the tips would have to be changed repeatedly to achieve
an air seal. A DNE ruled out enlarged adenoid as a confounding factor before the procedure.
Balloon Eustachian tuboplasty is a popular tool used widely for OETD. Several studies
have been performed and reported in the past justifying its use.[9],[12]-[14] The clinical consensus statement on balloon dilation of Eustachian tube found no
scientifically proven or standard medical therapy for OETD.[15] They also concluded that the modified VM was appropriate to test the function of
the Eustachian tube.[15] Han et al, in their study, concluded that VM could be the first-line therapeutic
modality in otitis media with effusion in adult patients who demonstrated successful
maneuver results on otoendoscopic examination.[16] Hence, we chose this maneuver as a control in our study.
Transtympanic balloon dilation has also been tried and tested successfully.[17] The results of balloon dilation of Eustachian tube and medical treatments were 51.8
and 62.2% at 6 and 12 weeks, respectively, while in controls (medical therapy alone),
it was 13.9 and 8.5% in the same period.[18] These results are comparable with that of ours. However, balloon dilation requires
preoperative high-resolution computed tomography of the temporal bone of the patient.
Besides the procedure itself is invasive, requires general anesthesia, operation theatre
setup, and has its own complications.[19] It is also expensive and cannot be repeated due to patient morbidity. The procedure
also does not address the obstruction in the bony part of the Eustachian tube. McCoul
et al, in their study, concluded that the dilation of the Eustachian tube carried
a substantial financial expense. Hence, there was a need to develop alternative therapeutic
procedures to mitigate invasive procedures.[20] The device of our study overcomes all these disadvantages and is also both diagnostic
and therapeutic.
Further studies with a larger sample size are required to verify the duration of this
therapeutic effect in the long term. Studies are also needed to check the optimum
pressure needed for the best outcome. Randomized studies could also be performed along
with balloon dilation to compare their effects on middle ear surgery. However, the
disadvantage of this device is that the Eustachian tube can be treated only in the
presence of a perforation in the tympanic membrane and also, the procedure needs to
be repeated multiple times for an apparent therapeutic effect.
Conclusion
The EBT is a simple, inexpensive device that can be easily used to treat OETD in quiescent
and dry stages of mucosal COM. The net success rate (partial and complete recovery)
was 92%. The therapeutic effect of this device is faster and superior to that of the
VM (success rate—46.66%) and comparable with balloon tubal dilation. The device is
particularly suitable for the developing countries at the rural and peripheral health
care centers where expensive diagnostic and therapeutic equipment may not be available.
